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Paragon 28

Last updated September 17, 2026

Information

Country: US
Address: 14445 Grasslands Dr., Englewood, CO, 80112
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3008650117
DUNS Number: —

Catalogue (5858)

Page 27 of 118

Device	Model / Reference	Registries	Class	Status
Baby Gorilla®/Gorilla® Plating System	P50-853-4722	FDA UDI	Class II	Active
Monster Screw System	P26-772-100F	FDA UDI	Class II	Active
Gorilla Plating System	P50-900-UNVC-2	FDA UDI	Class I	Active
Gorilla Plating System	P53-104-0020	FDA UDI	Class II	Active
Monster Screw System	P20-570-070S	FDA UDI	Class II	Active
Monster Screw System	P26-772-160M	FDA UDI	Class II	Active
Monster Screw System	P20-427-032S	FDA UDI	Class II	Active
Monster Screw System	P26-550-075M	FDA UDI	Class II	Active
Monster Screw System	P26-931-7200	FDA UDI	Class I	Active
Gorilla Plating System	P50-053-3524	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-4250	FDA UDI	Class II	Active
Monster Screw System	P20-440-030S	FDA UDI	Class II	Active
Monster Screw System	P20-135-010F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-815-350R-S	FDA UDI	Class II	Active
Gorilla Plating System	P50-253-4255	FDA UDI	Class II	Active
Monster Screw System	P20-440-034F	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-453-3508	FDA UDI	Class II	Active
Monster Screw System	P99-998-1424	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P53-108-L011	FDA UDI	Class II	Active
Monster Screw System	P26-750-100M	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-900-035R	FDA UDI	Class II	Active
Bun-Yo-Matic™ Lapidus Clamp System	P30-196-2319	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-111-R001	FDA UDI	Class II	Active
Bun-Yo-Matic™ Lapidus Clamp System	P30-960-1202L	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31P-I316-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BL5L-S	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-180-BL3S-S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-950-0004	FDA UDI	Class II	Active
JAWS Nitinol Staple System	P71-010-1010-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I519	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-900-MTPL-03	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-950-0057	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-202-2000-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-300-150L-S	FDA UDI	Class II	Active
TenoTac Soft Tissue Fixation System	P42-931-T154	FDA UDI	Class I	Active
Gorilla Plating System	P50-153-3516	FDA UDI	Class II	Active
Gorilla Plating System	P01-900-0002	FDA UDI	Class I	Active
Monster Screw System	P26-772-110F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-600-175R-S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-900-FIB1	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-014-R002	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-112-0160	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-903-CAD1	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-853-4732	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-120-0160	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-908-0013	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-653-4555	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-224-0130	FDA UDI	Class II	Active
Gorilla Plating System	P53-109-R112	FDA UDI	Class II	Active
Grappler™ Suture Anchor System	P44-120-4515-SK	FDA UDI	Class II	Active

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 28, 2018	Z-0662-2020	—	terminated	It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could result in improper preparation of the surgical site causing delays in surgery.
Dec 19, 2017	Z-2261-2018	—	terminated	Missing drill guide as stated in the package.